CLINICAL TRIALS & RESEARCH
Dr. Ann Wierman as Principal Investigator in Clinical Trials
Consultant/Speaker for Novartis, Celgene and Genentech (2008-Present)
- Sponsor: Aventis/UW - A Phase III Randomized Study of Three Different Doses of Docetaxel as First Line Treatment in Metastatic Breast Cancer.
- Sponsor: Genentech - Clinical Outcomes in Patients with HER2 Gene-Amplified Metastatic Breast Cancer Treated with First Line Herceptin in Combination with a Taxane: A Phase IV Prospective, Community-Based Study.
- Sponsor: Celgene - A Multi-Center, Single-Arm, Open Label Study to Evaluate the Safety and Efficacy of Single Agent CC-5013 in Subjects with Relapsed and Refractory Multiple Myeloma.
- Sponsor: Genentech - A Phase III Randomized, Double-Blind, Multi-Center Trial of OCI-774 Plus Chemotherapy (Carboplatin and Paclitaxel) vs. Chemotherapy Alone in Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy.
- Sponsor: Novartis – Prospective, Multi-Center, Open-Label, Clinical Evaluation of the Effect of I.V. Zometa 4 mg on Pain, Quality of Life and Time in Infusion Chair with Breast Cancer, Multiple Myeloma and Prostate Cancer Patients with Cancer-Related Bone Lesions.
- Results of a Multicenter Open-Label Randomized Trial Evaluating Infusion Duration of Zoledronic Acid in Multiple Myeloma Patients (the ZMAX Trial).
- An Expanded Access Program For Lenalidomide Plus Dexamethasone In Previously Treated Subjects With Multiple Myeloma.
- Symptom Management and Supportive Care Safety and Pain Palliation of Zoledronic Acid in Patients with Breast Cancer, Prostate Cancer, or Multiple Myeloma Who Previously Received Bisphosphonate Therapy.
Dr. Ann Wierman Clinical Trials with NCI
- MERCK-Serono - 100070-001 - A phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of Avelumab in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.
- SWOG – S0702 A prospective observational multicenter cohort study to assess the incidence of osteonecrosis of the jaw (ONJ) in cancer patients with bone metastases starting Zoledronic acid treatment.
- GOG – Gynecologic Oncology Group - A randomized phase III trial of carboplatin and paclitaxel 175 mg/m2 Q 21 days x 3 courses versus the same regimen x 6 courses in patients with selected stage IC and II (A, B, C) and selected IA and IB ovarian cancer.
- CTSU-MA.27: A Randomized Phase III Trial of Exemestane versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer.
- ECOG - PACCT-1, Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial.
- SWOG S0221 Phase III Trial of Continuous Schedule AC+G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node Negative Breast Cancer.
- NSABP R-04 A Phase III Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum.
- CALGB 9730 - Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness.
- DM97-022 MDA- MD Anderson - A Randomized Phase II Trial of Taxol/VP-16/Estramustine Vs. Ketoconazole/Doxorubicin/Vinblastine/Estramustine in Androgen Independent Prostate Cancer.
- NSABP-B23 A Clinical Trial Comparing Short Intensive AC ± Tamoxifen with Conventional CMF ± Tamoxifen in Node-Negative Breast Cancer Patients With ER-Negative Tumors.
- UMCC – University of Michigan Phase II Trial of Encapsulized Ginger as a Treatment for Chemotherpay Induced Nausea and Vomiting.
- NSABP B-38 A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/ Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC -> P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC -> PG).
- NSABP B-28A Randomized Trial Evaluating the Worth of Paclitaxel (Taxol) Following Doxorubicin (Adriamycin)/Cyclophosphamide in Breast Cancer Patients With Positive Axillary Nodes.
- CALGB 40101 Cyclophosphamide and Doxorubicin (AC 4 vs 6 Cycles) versus Paclitaxel (4 Weeks vs 6 Weeks) as Adjuvant Therapy for Women with Node-Negative Breast Cancer: A 2x2 Factorial Phase III Randomized Study.
- CALGB 9491- Postoperative Evaluation of 5-FU by Bolus Injection Vs. 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT Vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT in Patients with Rectal Cancer, Phase III Intergroup.
- CALGB 9741: A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14- or 21-Day Intervals in Women with Node Positive Stage II/IIIA Breast Cancer.
- CALGB 90206 A Randomized Phase III Trial of Interferon Alfa-2b or Interferon Alfa-2b plus Bevacizumab in Patients with Advanced Renal Carcinoma.
- GOG 150, A Phase III Randomized Study of Whole Abdominal Radiotherapy (War) versus Combination Ifosfamide-Mesna with Cisplatin in Optimally Debulked Stage I, II, III or IV Carcinosarcoma (CS) of the Uterus.
- NSABP B-34 A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Tamoxifen or No Therapy.
- NSABP-C06 A Clinical Trial Comparing Oral Uracil/Ftorafur (UFT) Plus Leucovorin (LV) with 5-Fluorouracil (5-FU) Plus LV in the Treatment of Patients with Stages II and III Carcinoma of the Colon.
- NSABP LTS-01, Patient Reported Outcomes in Long-Term Survivors with Colon and Rectal Cancer.
- ECOG E2804-The BeST Trial: A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advance Renal Cell Carcinoma.
- CALGB 90104 A Randomized Phase III Study Comparing Sequential Chemotherapy (AG-TP) to Cisplatin and Gemcitabine (GC) as Adjuvant Treatment After Cystectomy for Transitional Cell Carcinoma of the Bladder.
- NSABP C-08 A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the treatment of Patients With Resected Stages II and III Carcinoma of the Colon.